So what is going on in the realm of PrEP for women? TheBody.com spoke with Valery Hughes, a nurse practitioner who has been providing HIV care since the dawn of the epidemic. Today, she's helping to run a PrEP study just for women -- and it's enrolling now. Hughes shares her expertise and opinions on how HIV-negative women will get PrEP (and what barriers they may face); comparisons between PrEP and birth-control pills; what non-HIV-specialist docs ought to know about PrEP; how far we've come in all areas of the epidemic since the dark days of the '80s; and how far we have still to go.

Having worked in the community providing HIV care for for as long as you have, and now working on this HIV prevention drug study, what do you think the rollout of PrEP for women is going to look like? What do you think will be the most effective way to go about it?

There are a bunch of issues to consider. I think the first is: Should we link any kind of HIV prevention to primary care? I know a lot of physicians are thinking about that. I think it's a great idea, because, of course, the more people we get into primary care, the more we can discuss the full issue of sexual health, including testing and treating for other STIs (sexually transmitted infections) and preventing other viral infections, such as HPV (human papillomavirus), hepatitis B and hepatitis C. But I'm not sure if that's the best idea.

I think that, in my professional heart, I would love to see this linked to primary care. But I can see that there are going to be some obstacles for that. Because I think a lot of women don't have access to primary care. I think we're talking about people with limited insurance, or possibly no insurance. And I'm wondering whether there would be a better way to roll it out with easier access, without so much bureaucracy and without so much money involved, sort of in the Department of Health model.

I think the Department of Health does a great job in STI surveillance and treatment. And it's pretty easily accessible. However, there are some issues with PrEP that aren't there when you do testing and empiric treatment of STIs. Part of that, of course, is the long-term monitoring of side effects. So, there are two ways that I can see it going: one, as I say, linked to primary care; and the other in a sort of more accessible way.

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Can you explain the Department of Health model around STI surveillance, and how that relates to PrEP availability?

If a person thinks they may have been exposed to an STI -- if they get a call from their friend saying, "I just tested positive for syphilis; you should get tested" -- you can actually just walk into the Department of Health at any time and they'll test you and treat you right then and there. No money up front. There is a fair amount of waiting around at the Department of Health. But they're very good about that. So it's a great, accessible model.

However, in these cases, they're testing and treating for something that is in existence; PrEP is a different thing because it's trying to prevent something that, of course, hasn't happened yet. And here's the crux of the problem: If you are going to take a medicine for a disease that you have that's going to fix something that's broken, that's a very, very different thing than taking medication for something you don't have yet. And so there have to be more safety tools in place in order to prevent people from having side effects from whatever medication we end up using for PrEP.

Speaking of taking medications to prevent something from happening: What do you think of the comparison that's occasionally made between PrEP and "the Pill" to prevent pregnancy? They both need to be taken every day in order for them to work properly; but is this an apt comparison? What are the points of similarity and difference between these two prophylactic medications?

I think in the ways in which they're similar, they do confer freedom to be sexually active in a less restrictive way. That certainly was, I think, [PrEP consumer and advocate] Damon Jacobs' whole argument in comparing the Pill and PrEP.

But a glaring difference is that pregnancy is one form of consequence of sexual activity, while HIV is one of several -- arguably the worst, some would say -- of all the STIs that can be the consequence of sexual activity. Part of the issue with PrEP is that it's protecting against only one of the possible consequences of sexual activity. So they're alike in some ways, and very different in other ways.

"The consequence of getting pregnant is very, very different than the consequence of getting a disease. ... However, if it's something that you have to take every day -- and women have proven that that can happen -- then I think we need to look at the comparisons in a positive way."

I used to hear all the time that pregnancy could be a serious health risk for a woman. Well, I think that's kind of a silly argument for birth control. I think birth control has all sorts of things to recommend it. But the consequence of getting pregnant is very, very different than the consequence of getting a disease. So I really think that they are, emotionally and in all sorts of other ways, a very, very different kettle of fish.

However, if it's something that you have to take every day -- and women have proven that that can happen -- then I think we need to look at the comparisons in a positive way.

As has been said in commentary on recent PrEP study results, particularly those that proved unsuccessful: PrEP works if you take it -- if people are able to be adherent to it, and take it every day. The recent disappointing results of the VOICE study gave nods to the fact that there are all sorts of different challenges that come up in people's lives that make it hard to adhere to meds -- and we know that's the case even for conditions a person already has. Would you talk a little bit about that?

Using VOICE as an example is interesting, because it does sort of highlight the difference between women in sub-Saharan Africa, where the study was conducted, and women in New York City. They have very different priorities and very different lives.

Another thing about VOICE was that it was a three-arm study; one of the arms was a microbicide gel form of tenofovir (Viread). I think what was definitely part of the issue with non-adherence there was the acceptability of gel. Which is really one of the endpoints of the study: They found that women don't like to use the gel. So that tells the story right there.

But regarding swallowing the pills every day: I wish they had parsed out some of the reasons why women did not take the pills. I understand that they did have a questionnaire in the VOICE study and that, by questionnaire, women were 90 percent adherent; whereas in pill returns and in blood levels, they were obviously much less than that. So that speaks to that whole issue of: Why would you go forward and accept a prescription for a medication, or even accept a bottle of pills, and then not swallow them?

There are two things that occur to me. One is that life in Africa is very different than life here. And a lot of times I've found some of my patients who are from Africa often will take the meds that I give them and ship them home to family members who have HIV. So I think that that could be part of the problem. It could also be that perhaps people just cannot find it in their schedule to take medications every day, when they have a different type of life.

Or it could be that, like all women, they have so many competing priorities that their health comes last. And I think that's probably, for me, the biggest challenge to getting women to take PrEP: Their health always comes last. On the spectrum of things to do, taking care of my health is always at the last. I think that's what happens with a lot of women.

Going back to what you mentioned earlier about potentially incorporating PrEP into primary care: Our community, the HIV-affected community, is clearly the arena where there's the most PrEP knowledge (and the most PrEP conflict), but out in the realm of general primary care, maybe that's not necessarily happening. Maybe there are even misunderstandings about HIV itself, much less prophylactic pills for it.

In an ideal world, what do you think training and education would look like for non-HIV specialist primary care providers about PrEP? And what might it actually look like in the non-ideal world that we currently live in?

Well, of course, in the ideal world, if there's a new therapy we would all get trained; we would all find out about ideal dosing; possible side effects; how to monitor; how to assess adherence; how to assess for other sexual health issues. It would be a whole day event, I think.

But in the real world, I think the big take-away would be that PrEP has to be combined with frequent HIV testing, at least every three months, and periodic renal monitoring if we're going to use Truvada (tenofovir/FTC); and possibly even bone density monitoring.

I think we don't have the answers to those questions about what is the ideal way to monitor people who are on PrEP, and I'm hoping that further studies will help to clarify that. But once again, you want to make sure that people are getting tested at least every three months because you don't want people to be on substandard HIV treatment if they do, in fact, become HIV positive while taking PrEP.

If there was one key point that you would want a provider -- someone who may not have PrEP be a regular part of their practice, but might have one or two patients that they'd consider referring -- to take away from their hypothetical, brief PrEP training, what would that point be?

I guess probably the most important one would be the frequent HIV testing; that would be the first one. And the second would be monitoring for side effects. So, periodically get them in and look at the creatinine. See what's going on there and see what's happening with renal function.

One of the things about tenofovir is that it's a great drug until it's not a great drug. And then if the person happens to be one of the very, very few that are affected by it, in terms of a little damage to the kidneys, then it's one of the things you want to catch early. Every drug has warts; even aspirin has warts. So we have to really pay attention. We can't just be writing prescriptions out without any kind of follow up.

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